Study: No increased risk of neoplasm in patients with CKD, anemia who receive roxadustat
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Patients with anemia and chronic kidney disease who receive roxadustat do not show an increased rate of neoplasm-related treatment-emergent adverse events and treatment-emergent serious adverse events, according to presented data.
“There was no clinically meaningful between-treatment-group differences in the exposure-adjusted incidence rate of neoplasm-related [treatment-emergent adverse events] TEAEs and [treatment-emergent serious adverse events] TESAEs from the roxadustat global phase 3 clinical trials,” Daniel W. Coyne, MD, said during his presentation at ASN Kidney Week.
Researchers included pooled data from six phase 3 studies. The OLYMPUS, ANDES and ALPS trials were used for patients with nondialysis-dependent CKD. The ROCKIES, SIERRAS and HIMALAYAS trials were used to study patients with dialysis-dependent CKD.
Patients with a history of malignancy, except for patients who were cured or in remission for 5 or more years, had curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ or resected colon polyps, were excluded. Adverse events were summarized under the system organ class as benign, malignant or unspecified.
For patients with NDD-CKD, the duration of exposure was longer in the roxadustat arm because the ANDES and ALPS trials randomized patients 2:1, thus creating an imbalance in the roxadustat arm, he said. The mean duration of exposure was 84.6 weeks for patients who received roxadustat and 64.3 weeks for patients who received placebo.
For patients with NDD-CKD, 4,270 patients were randomized to receive either roxadustat or placebo. Overall, 46% to 47% of patients were older than 65 years. Researchers found neoplasm-related adverse events rates were 2.5/100 patient-exposure years for both groups. Neoplasm-related serious adverse events rates were 1.1/100 patient-exposure years in the roxadustat group and 1.3/100 patient-exposure years in the placebo group.
For patients with dialysis-dependent CKD, 3,880 patients were randomized to receive either roxadustat or epoetin alfa. Overall, 26% to 27% of patients were older than 65 years. The mean duration of exposure was 89.2 weeks for patients who received roxadustat and 100.7 weeks for patients who received epoetin alfa.
Researchers found the neoplasm-related adverse events rates were 2.7/100 patient-exposure years in the roxadustat group and 2.3/100 patient-exposure years for patients who received epoetin alfa. Neoplasm-related serious adverse events rates were 1.1/100 patient-exposure years and 1.2/100 patient-exposure years.
Coyne said there were no significant differences in organ types of neoplasms among study arms.
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Coyne DW, et al. Paper TH-OR04. Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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